NCT06664957

Vitamin C's Antioxidant Effects and COPD Prognosis

The Role of the Antioxidant Effects of Vitamin C in Improving the Prognosis of Patients With Chronic Obstructive Pulmonary Disease: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of Vitamin C supplementation in improving the prognosis of patients with Chronic Obstructive Pulmonary Disease (COPD) through its antioxidant effects. The primary objectives of the study are to determine: 1. Whether Vitamin C reduces the frequency of acute COPD exacerbations. 2. Whether Vitamin C improves pulmonary function and health-related quality of life in patients with COPD. The study will compare Vitamin C to a placebo to assess its impact on oxidative stress and its potential to enhance clinical outcomes in COPD management. Participants will: 1. Receive either daily oral Vitamin C supplementation or a placebo for a period of 6 months. Undergo monthly clinical evaluations, including spirometry and symptom assessments. 2. Report any adverse events or health changes during the trial.

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin C (Ascorbic Acid)	Participants in this arm will receive 400 mg of Vitamin C, administered as two 100 mg tablets in the morning and two 100 mg tablets in the evening, for a total of 12 months. The intervention aims to support antioxidant defense and improve clinical outcomes in COPD patients.
OTHER	Placebo	Participants in this group will receive a placebo, identical in appearance to the active nutrient supplement (Vitamin C) tablets, with no active ingredients. The placebo will be administered as two tablets in the morning and two tablets in the evening (four tablets per day) for a duration of 12 months, serving as a control to compare the effects of the active intervention.

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-10-30
• Last updated: 2024-12-17